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Effect of adding milk supplement to mothers milk after discharge from the hospital on the brain development in preterm infants

Long term neurodevelopmental outcome in Very Low Birth Weight (VLBW) preterm infants receiving post-discharge fortification in a resource limited setting: A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092744
Enrollment
200
Registered
2025-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: Bovine-based Human Milk Fortifier (Lactodex powder, 1 g sachet, Raptokas Brett & Co Ltd, India with composition of 0.27g protein,0.04g fat,0.49g carbohydrates, 15.8mg Calcium, 7.9mg pho

Sponsors

Seth GS Medical College and KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn neonates less than 37 completed weeks of gestation with birth weight less than 1500 grams who were on either mother s milk or pasteurized donor human milk supplemented with bovine-derived HMF will be enrolled in the study within 48 hours before discharge.

Exclusion criteria

Exclusion criteria: Preterm infants who do not tolerate HMF, infants with severe intraventricular hemorrhage (IVH), posthemorrhagic ventricular dilatation (PHVD), meningitis, surgical conditions, congenital anomalies and cyanotic congenital heart disease will be excluded.

Design outcomes

Primary

MeasureTime frame
Neurodevelopmental outcome at 12 months corrected age in very low birth weight preterm infants receiving post discharge fortification and those receiving unfortified feeds after discharge.Timepoint: 12 months corrected age—

Secondary

MeasureTime frame
1. Gain in weight, length and head circumference till 40 weeks postmenstrual ageTimepoint: 40 weeks gestation, 3,6,9 and 12 months of age;Incidence of feed intolerance post dischargeTimepoint: Any time after discharge while infant is still on human milk fortification;Anemia of prematurityTimepoint: within 3 months post discharge;Retinopathy of prematurityTimepoint: 3 weeks till 12 weeks;MortalityTimepoint: Any time after discharge while infant is still on human milk fortification—

Countries

India

Contacts

Public ContactAnitha Haribalakrishna

Seth GS Medical College and King Edward Memorial Hospital

ani.gem81@gmail.com9769660870

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026